To Study the Efficacy and Safety of Renessans in Chronic HCV Patients

NCT01463592 | Unknown Phase 3 DMC

• 1 other identifier: REN1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic HCV infection is one of the common causes of the chronic liver disease. Approximately 6-10% of the general public is expected to be suffering from this infection. In case that these patients are not treated at an appropriate time, these patients develop the sequelae of the chronic liver disease e.g. cirrhosis of liver, Ascites, and Hepatocellular carinoma. Interferon alpha 2 a or alpha 2b injections and Ribavirin combination is the treatment of choice for people suffering from Chronic HCV infection and this combination need to be administered for 6-12 months. Interferons are biological agents and are to be administered parenterally. Interferons are expensive and are associated with number of minor and major adverse effects. Ribavirin is also associated with significant adverse effects. These compounds cannot be considered as one of the ideal forms of the treatment. In the past, quite a few natural products have been tested to assess their hepatoprotective activity and possibly anti viral activity as well. These include Vitamin C (Ascorbic acid), Vitamin E, Zinc, Silymarin, Red beet roots, crushed licorice and etc. etc. Rationale Iodine , Potassium iodide and Ascorbic acid are natural products used in the management of Thyroiditis and chronic cutaneous fungal infections. This combination of iodine compounds along with ascorbic acid is being used for the management of chronic hepatitis B \& C in the central Asian states e.g. Kazakhstan etc. The investigators have conducted a feasibility study in which oral Iodine Compound {RENESSANS} was given to patients suffering HCV related Chronic Active Hepatitis and anti-viral activity and safety has been analyzed. In this study, RENESSANS containing regimen has been well tolerated by all the patients and has shown some antiviral activity. In this study the investigators will assess whether the administration of RENESSANS {oral } improves the antiviral activity in patients receiving standard interferon therapy.

Conditions

Hepatitis C, Chronic

Keywords

Renessans; HCV

Outcome Measures

Primary Outcomes (1)

• Efficacy of Renessans based triple therapy versus dual therapy

  Efficacy will be assessed by biochemical and virological response. Biochemical response will be assessed in the form of mean decline in ALT from baseline at 3 month and end of treatment. Virological response will be assessed in the form of response guided therapy i-e RVR \[negative RNA at week 4\],EVR \[negative RNA at 12 weeks\],ETR \[negative RNA at end of treatment\] and SVR\[negative PCR after 6 month of completion of therapy\].

  03 years

Secondary Outcomes (1)

• Assess the safety and tolerability of Renessans in patients with chronic HCV patients

  3.5 years

Study Arms (3)

Group II a

EXPERIMENTAL

TRIPPLE THERAPY

Biological: RENESSANS , INTERFERON ALPHA 2b, Ribavirin

Group II b

ACTIVE COMPARATOR

DUAL THERAPY

Drug: Interferon Alfa-2b AND RIBAVIRIN

Group I

EXPERIMENTAL

ORAL RENESSANS

Biological: RENESSANS

Interventions

RENESSANS , INTERFERON ALPHA 2b, Ribavirin BIOLOGICAL

ORAL RENESSANS 5gm. Twice Daily +INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg

Also known as: IODINE POLYMER, HEBERON, VIRON

Group II a

Interferon Alfa-2b AND RIBAVIRIN DRUG

INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg

Also known as: HEBERON, VIRON

Group II b

RENESSANS BIOLOGICAL

ORAL RENESSANS 5gm. Thrice Daily{active iodine 300mg} for 6months

Also known as: IODINE POLYMER

Group I

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Following groups of the people will be enrolled for the study.
• Patients suffering from chronic HCV infection as evident with a positive serology for Anti HCV antibody and raised ALT.
• Both males and females
• Age group: 18 - 55 years
• Informed consent

You may not qualify if:

• Following groups of people will be excluded from the study
• Pregnant females
• Body mass index more than 25
• Uncontrolled Diabetes Mellitus, Hypertension, Ischemic heart disease, Renal failure, Respiratory failure, Chronic infections, gall stone disease or renal stone disease.
• Patients known to have hypersensitivity to Iodine compounds in the past.
• Psychiatric disorders except mild anxiety disorders.
• Patients suffering from auto immune diseases e.g. Rheumatoid Arthritis, SLE, or thyroid diseases.
• Patients suffering from concomitant HBV infection, HIV infection or any other chronic liver disease.
• Bilirubin more than 2mg/dl, Albumin less than 3.0 gms/dl, INR more than 1.5, Hb. less than 10 gms /dl, absolute neutrophil count less than 1500/cmm and platelet count less than 100,000/cmm
• Serum sodium less than 130mmol/l.
• Patients who have received the interferon treatment in the past.

Sponsors & Collaborators

• MTI Medical Private Limited, Pakistan: lead

Study Sites (1)

Medical Unit 1,Lahore General Hospital,Postgraduate Medical Institute

Lahore, Punjab Province, 42200, Pakistan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Interferon alpha-2; Ribavirin; viron

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• GHIAS UN NABI, FCPS,MRCP

  PROFESSOR OF MEDICINE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: November 2, 2011
• Study Start: June 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 22, 2011

Record last verified: 2011-10

Locations

PA (1)